The experimental use doctrine is a common law rule in patent law that until a few years ago excused accused infringers who made and used patented products or processes on the basis of an experimental, educational, or nonprofit purpose when there was de minimis economic injury to the patent owner and de minimis economic gain to the infringer. While the application of the experimental purpose doctrine was always narrow, two recent Federal Circuit decisions indicate that there is not much left under its aegis. In Madey v. Duke University, the Federal Circuit strictly limited the application of the experimental purpose doctrine to those endeavors which are "solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry." A year later, in Integra Lifesciences I, Ltd. v. Merck KGaA the Federal Circuit held that the safe harbor provision in the Hatch-Waxman Acte would not shield defendants who infringe patents while identifying new drug candidates. Although these two decisions strengthened the protection of patents, they also alarmed some commentators because of their potential negative impact on academic research, particularly biomedical research. This Note presents both empirical data and an economic analysis of the interaction between universities and the biotechnology industry to show that Madey and Integra were decided correctly, and that the concerns expressed by Madey and Integra's critics are unfounded. In Part I, this Note reviews the historical development and current status of the experimental purpose doctrine. Next, Part II argues that given that the line between academia and the biotechnology industry has blurred, if not totally disappeared, patent law should not provide universities and non-profit research institutions special protection under the experimental purpose doctrine. To support this argument, Part II surveys the extensive involvement of universities in industry and presents an empirical study of patent infringement suits between universities and industry. Lastly, Part III presents an economic analysis of the experimental purpose doctrine based on the empirical data presented in Part II. Part III argues that the empirical evidence suggests that universities are not in danger of being overwhelmed by the patent litigation mounted by the biotechnology industry.
The Experimental Purpose Doctrine and Biomedical Research,
Mich. Telecomm. & Tech. L. Rev.
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